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TSO3 Establishes Claims for Duodenoscope Terminal Sterilization

Dec 21, 2015

TSO3 Inc., an innovator in sterilization technology for medical devices in healthcare settings, has added to its label claims for the STERIZONE® VP4 sterilizer in Canada that validates the ability to sterilize a specific duodenoscope.

Duodenoscopes are multi-channel endoscopic devices with flexible lighted tubes that are typically threaded through the mouth, throat and stomach and into the top of the small intestine (duodenum). They are used in an increasingly common procedure called endoscopic retrograde cholangiopancreatography (ERCP). ERCP is used primarily to diagnose and treat conditions of the bile ducts and main pancreatic duct, including gallstones, inflammatory strictures, leaks (from trauma and surgery) and cancer.

Duodenoscopes are complex endoscopes, with small working parts that include an elevator guide-wire mechanism that is difficult to reach when reprocessing. This is compounded by the fact that the design varies across brands and models. However, if a duodenoscope is not meticulously reprocessed, living microbes harboring in residual tissue or fluid from a prior procedure can be transmitted via the scope to a subsequent patient.

TSO3 has established laboratory data that validates that the STERIZONE® VP4 sterilizer, with its dual sterilants of hydrogen peroxide and ozone, can repeatedly sterilize the Olympus TJF-Q180V Duodenoscope, the industry's leading brand and model of duodenoscope.

"We believe we are the first to validate terminal sterilization of such a device," says TSO3 president and CEO, R.M. Rumble. "This breakthrough comes at a critical time, with the growing use of Duodenoscopes, along with the increasing number of adverse incidents related to ineffectual reprocessing."

Only this particular Olympus Duodenoscope has been validated and is included in our Canadian label claim and Rumble points out that TSO3 does not expressly or implicitly claim that the medical device manufacturer has cooperated in performing the tests or has endorsed the test results.

"We are planning to meet with the U.S. FDA in early 2016 to discuss the addition of similar language for our claims in the U.S.," adds Rumble.

Duodenoscopes have been directly linked to patient-to-patient transfer of multidrug-resistant bacteria that are not inactivated by high-level disinfection. Published reports confirm the significant risk of device-related transfer of antibiotic resistant microbes, which can lead to patient injury or death.

According to a report published in The L.A. Times in August regarding an ERCP-related superbug outbreak at UCLA, nearly 700,000 ERCP procedures were performed in the U.S. last year, up more than 14 percent since 2010.

In October, the FDA issued an official statement ordering duodenoscope manufacturers to conduct post market surveillance studies in healthcare facilities.

The STERIZONE® VP4 Sterilizer is a low-temperature (41°C or 105.8°F) sterilization system that utilizes the dual-sterilants of vaporized hydrogen peroxide (H2O2) and ozone (O3) to achieve terminal sterilization of heat and moisture sensitive medical devices. Its single pre-programmed cycle can sterilize a large number and wide range of compatible devices, creating a cost-effective, error-free sterilization process. The device's unique Dynamic Sterilant Delivery System™ automatically adjusts the quantity of injected sterilant based on the load composition, weight and temperature. This capability removes the guesswork and potential for human error, as there is no need to sort instruments and choose the appropriate cycles as with other machines.

The STERIZONE® VP4 Sterilizer can process a mixed load consisting of general instruments, single channel flexible endoscopes, and single or double channel rigid endoscopes in the same cycle with load weights of up to 75 pounds. This ability to run mixed loads significantly reduces labor costs by minimizing the amount of instrument sorting required, while maximizing the device turns (more productivity from increased throughput capacity). The STERIZONE® VP4 Sterilizer was cleared for commercialization in the United States in December 2014 and in Canada in October 2015.